Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial

NCT02978729 | Completed

• 1 other identifier: 824225
• Study Type: interventional
• Target: 613
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare two methods for remote genetic counseling (telephone and two-way videoconferencing) for patients who are receiving disclosure of their APOE (apolipoprotein E) genotype. The target population will consist of males and females in the age range of 60-75 years who, as potential participants in a study (Generation Study), will need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing to receive genetic counseling and disclosure remotely. Subjects must be willing to be randomized to either telephone arm or videoconference arm.

Conditions

Alzheimer Disease; Genetic Predisposition to Disease

Keywords

Telemedicine; Counseling, Genetic

Outcome Measures

Primary Outcomes (2)

• Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale

  2-7 days

• Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale

  2-7 days

Secondary Outcomes (7)

• Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale

  2-7 days, 6 weeks, 6 months, 12 months

• Disease-specific distress as measured by the Impact of Events Scale

  2-7 days, 6 weeks, 6 months, 12 months

• Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms

  2-7 days, 6 weeks, 6 months, 12 months

• Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale

  2-7 days, 6 weeks, 6 months, 12 months

• Depression as measured by the GDS Short Form

  2-7 days, 6 weeks, 6 months, 12 months

Study Arms (2)

Telephone

ACTIVE COMPARATOR

Telephone telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via telephone. The participant will be in a private room at the study site. Telephone sessions will utilize a private phone line. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session.

Other: Telephone remote genetic counseling

Videoconference

EXPERIMENTAL

Two-way videoconferencing telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via two-way videoconferencing. The participant will be in a private room at the study site. Videoconferencing sessions will utilize tablets or laptops with web cameras and secure/confidential software for teleconferencing. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session.

Other: Two-way videoconference remote genetic counseling

Interventions

Two-way videoconference remote genetic counseling OTHER

Videoconference

Telephone remote genetic counseling OTHER

Telephone

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible to participate in the Generation Study
• Ability to provide consent
• Ability to communicate and hear in English

Sponsors & Collaborators

• University of Pennsylvania: lead

MeSH Terms

Conditions

Alzheimer Disease; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela R Bradbury, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: December 1, 2016
• Study Start: August 1, 2016
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share